Reduced-Intensity Busulfan and Fludarabine With or Without Antithymocyte Globulin Followed by Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Disease

Summary

RATIONALE: Giving low doses of chemotherapy, such as busulfan and fludarabine, before a donor stem cell transplant helps stop the growth of cancer and abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer or abnormal cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Immunosuppressive therapy may improve bone marrow function and may be an effective treatment for hematologic cancer or other disease.

PURPOSE: This clinical trial is studying the side effects and how well giving busulfan and fludarabine with or without antithymocyte globulin followed by donor stem cell transplant works in treating patients with hematologic cancer or other disease.

Conditions

• Chronic Myeloproliferative Disorders
• Leukemia
• Lymphoma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes

Interventions

BIOLOGICAL

anti-thymocyte globulin

0.5 mg/kg on day -3, 2.5 mg/kg on day -2 (groups 2, 3 and 4) and 3 mg/kg on day -1 (group 4 only)

BIOLOGICAL

sargramostim

GM-CSF 500 ug everyday (QD) subcutaneously will be given to recipients who remain with an Absolute neutrophil count (ANC) \< 1000/microliter (uL) past day 20

BIOLOGICAL

therapeutic allogeneic lymphocytes

A minimum total cluster of differentiation 34 (CD34)+ cell dose of 3 x 10\^6 cells/kg and a maximum 8 x 10\^6 cells/kg will be infused on day 0

DRUG

busulfan

6.4 mg/kg by continuous IV infusion over 48 hours on Days -6 and -5

DRUG

fludarabine phosphate

fludarabine 30 mg/m\^2/day x 5 days IV piggyback (IVPB) over 30 minutes on Days -7 through -3

DRUG

methotrexate

Methotrexate 5 mg/m\^2 per day on days +1, +3 and +6

DRUG

tacrolimus

Suggested starting dose is 0.03 mg/kg po bid starting on Day -1

PROCEDURE

nonmyeloablative allogeneic hematopoietic stem cell transplantation

Minimum total CD34+ cells of 3 x 10\^6 cells/kg and a maximum of 8 x 10\^6 cells/kg will be infused on Day 0

PROCEDURE

peripheral blood stem cell transplantation

Minimum total CD34+ cells of 3 x 10\^6 cells/kg and a maximum of 8 x 10\^6 cells/kg will be infused on Day 0

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• UNC Lineberger Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Thomas C. Shea, MD · UNC Lineberger Comprehensive Cancer Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

10 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-01-07

Primary Completion

2011-01-11

Completion

2012-05-23

Countries

• United States

Study Locations